Neonatal CMV-Ganciclovir Follow-up Study
Completed
Conditions studied: Cytomegalovirus Infections
In brief
The purpose of this study is to document the developments associated with puberty and determine if any of the children who previously participated in another research study have been diagnosed with cancer. The previous study was a Collaborative Antiviral Study Group (CASG) protocol entitled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections." One of the medications used in this study to treat cytomegalovirus (CMV), ganciclovir, has been known to cause cancer and affect the development of gonads (ovaries in females and testes in males) when administered to animals. Children, 9-14 years old, who participated in the previous research study, will participate in this study for 1 day. Subjects will be evaluated by an endocrinologist and will have the following procedures performed: a complete physical examination, a single blood sample collected, an x-ray of the left wrist.
Key facts
- Study ID
- NCT00031421
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 8
- Starts
- 2001-09-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2011-08-12
Who can join
Age: 9 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children who received ganciclovir during the earlier study ("Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections), and if the parent or legal guardian signs an informed consent and the child signs an assent (where appropriate).
You may not qualify if…
- Any individuals not previously enrolled in the CASG protocol titled "Evaluation of Ganciclovir (DHPG) for the Treatment of Symptomatic Congenital Cytomegalovirus Infections"
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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